The Efficacy of Protein Supplementation on Attenuating Muscle Atrophy Following Disuse in the Collegiate Population

NCT03454347 | Completed

• 1 other identifier: IRB-1801014-EXP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Following orthopedic surgery and/or injury, a significant loss of muscle mass is generally observed. While this loss of muscle mass appears to be the norm, it causes significant problems in both the athletic and general population. Athletes struggle to regain their performance because of the decrease in muscle mass and also have a greater potential for reinjury while they are in a depleted state. In the general population, and particularly among the elderly, this loss in muscle mass can be even more devastating because as people age, it is more difficult to regain muscle after it is lost. In elderly individuals, this loss in muscle mass can lead to significant disability, diminished quality of life along with an increased risk of falls. In addition to the muscle mass lost during the post-operative period, the strength of the muscle also decreases. This has obvious performance implications in athletes, as well as having the potential to extend recovery time. In the elderly, decreased strength may result in reduced independence and inability to perform activities of daily living. Many previous bed rest studies have reported that significant bone loss also occurs during times of decreased mechanical loading. The post-operative period generally results in decreased mechanical loading; however, some muscle loading will still occur during the rehabilitation process. The dynamic relation between muscle activity/loading and bone density changes in the post-operative state has not been fully described and requires further study. With this knowledge of the importance of nutrition to the musculoskeletal system, applying the principles of increased protein intake through the addition of a dietary supplement to a population preparing for orthopedic surgery and subsequent muscle disuse is a logical next step. The investigators hypothesize that through the consumption of a protein-based dietary supplement three times per day (75g protein), along with educating patients on the importance of consuming foods that are high in protein, there will be an attenuation of decreases in muscle mass and strength as well as losses in bone that occur with orthopedic injury and disuse. The investigators long-term goal is to identify a nutritional protocol that can be implemented prior to and following orthopedic surgery to diminish the deleterious effects of the subsequent disuse on muscle and bone.

Conditions

Disuse Atrophy

Outcome Measures

Primary Outcomes (1)

• Muscle Mass

  Whole body muscle mass (kg) will be measured using DXA while muscle cross-sectional area of the lower leg will be measured via pQCT

  Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Secondary Outcomes (1)

• Muscle strength

  Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Other Outcomes (2)

• Volumetric bone mineral density

  Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

• Bone Cross-Sectional Area

  Measurements will be obtained prior to immediately following 2 weeks of lower limb suspension

Study Arms (2)

Protein Supplementation Group

EXPERIMENTAL

Participants in this group will complete two weeks of lower limb suspension and receive 75g/day of supplemental protein in addition to education aimed at increasing protein intake through their diet.

Dietary Supplement: Profile Perform

Non-Supplemental Group

ACTIVE COMPARATOR

Participants in this group will complete two weeks of lower limb suspension and will receive no supplementation or nutritional education.

Other: Lower Limb Suspension

Interventions

Profile Perform DIETARY_SUPPLEMENT

The dietary supplement includes 1.5 grams of fat, 19 grams of carbohydrate, and 25 grams of protein per serving. Participants in the experimental group will consume 3 servings per day.

Protein Supplementation Group

Lower Limb Suspension OTHER

This group will complete two weeks of lower limb suspension.

Non-Supplemental Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be physically active males and females aged 18-25 with no history of a lower extremity injury 12 months prior to participation. Physically active will be classified as participating in physical activity for at least 3 minutes and a minimum of 3 days per week.

You may not qualify if:

• Participants will be excluded if they are participating in any other research projects that could potentially affect the outcomes of this study.

Sponsors & Collaborators

• South Dakota State University: lead
• Sanford Research: collaborator

Study Sites (1)

South Dakota State University

Brookings, South Dakota, 57007, United States

Location

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 5, 2018
• Study Start: February 22, 2018
• Primary Completion: March 31, 2022
• Study Completion: May 10, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)